FDA grants Ambrx Biopharma a fast track designation for ARX517 for treating certain patients with metastatic castration-resistant prostate cancer.
NOxBOX recalls its NOxBOXi Nitric Oxide Delivery System due to a check valve misalignment in the devices manifold.
FDA clears the ReddyPort elbow device used in non-invasive ventilation.
FDA releases the form FDA-483 issued following an inspection at the Little Rock, AR-based SCA Pharmaceuticals outsourcing facility.
Mercks Keytruda with concurrent chemoradiotherapy meets the progression-free survival primary endpoint in an interim analysis of the KEYSTONE A-18 cer...
FDA clears an Xstrahl 510(k) for its Radiant Aura treatment device for providing radiation therapy to non-melanoma skin cancer patients.
FDA grants Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis.
FDA warns Mumbai, India-based Centaur Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
